Trial Search Results

Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors

This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in subjects with multiple tumor types.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Exelixis

Stanford Investigator(s):

Intervention(s):

  • Drug: cabozantinib
  • Drug: atezolizumab
  • Drug: cabozantinib
  • Drug: cabozantinib

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   1. Cytologically or histologically and radiologically confirmed solid tumor that is
   inoperable, locally advanced, metastatic, or recurrent:

      - Dose-Escalation Stage:

         - Subjects with UC (including renal pelvis, ureter, bladder, urethra) after
         prior platinum-based therapy, or

         - Subjects with RCC (clear cell, non-clear cell histology) with or without
         prior systemic anticancer therapy

      - Expansion Stage:

         - Inoperable locally advanced or metastatic solid tumor (UC, RCC, CRPC, NSCLC,
         TNBC, OC, EC, HCC, GC/GEJC/LEC, CRC, H&N cancer, and DTC as outlined above)

   2. Measurable disease per RECIST 1.1 as determined by the investigator.

   3. Tumor tissue material available (archival or recent tumor biopsy)

   4. Recovery to baseline or ‚ȧ Grade 1 CTCAE v4 from toxicities related to any prior
   treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive
   therapy.

   5. Age eighteen years or older on the day of consent.

   6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

   7. Adequate organ and marrow function.

   8. Sexually active fertile subjects and their partners must agree to use medically
   accepted methods of contraception.

   9. Female subjects of childbearing potential must not be pregnant at screening.

Exclusion Criteria:

   1. Prior treatment with cabozantinib or immune checkpoint inhibitors including
   anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy except in Expansion Cohorts
   5, 7, 9, 11, 17, 19 and 20. Other restrictions regarding prior therapy may apply.

   2. Known brain metastases or cranial epidural disease unless adequately treated and
   stable for at least 4 weeks before first dose of study treatment.

   3. Concomitant anticoagulation with oral anticoagulants.

   4. Subject is receiving systemic steroid therapy (>10 mg daily prednisone equivalent) or
   any other form of immunosuppressive therapy within 2 weeks prior to first dose of
   study treatment.

   5. Administration of a live, attenuated vaccine within 30 days before first dose of study
   treatment.

   6. The subject has uncontrolled, significant intercurrent or recent illness, including,
   but not limited to, an active or history of autoimmune disease or immune deficiency;
   idiopathic pulmonary fibrosis, organizing pneumonia, pneumonitis; active infection
   requiring systemic treatment, infection with human immunodeficiency virus (HIV),
   AIDS-related illness, acute or chronic hepatitis B or C infection, positive test for
   tuberculosis, moderate to severe hepatic impairment (Child-Pugh B or C).

   7. Pregnant or lactating females.

   8. Previously identified allergy or hypersensitivity to components of the study treatment
   formulations.

   9. Diagnosis of another malignancy within 2 years before first dose of study treatment.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Noel Jaclyn Del Toro
650-723-0574
Not Recruiting